National Safety Recall - Aug. 28

Saline solution may be contaminated, possibly causing embolism, organ damange or death.

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National Safety Recall - Aug. 28
Image: B. Braun

There is one genuinely new national recall today, involving B. Braun IV saline contaminated with particulate matter. There's also a significant Baxter saline recall posted August 26.

B. Braun IV saline — particles could cause embolism, organ damage or death

B. Braun Medical is recalling three lots of 0.9% Sodium Chloride Injection USP, 100 mL, after particulate matter identified as zinc oxide was found in the product. FDA posted the nationwide recall on August 28. (U.S. Food and Drug Administration)

The affected lots are J6B435, J6B444 and J6B457, expiration April 30, 2027. The saline was distributed nationwide to hospitals and health-care facilities from February 27 through August 3. (U.S. Food and Drug Administration)

FDA says intravenous infusion of particulate matter could cause pulmonary embolism, blocked blood vessels, tissue death, organ damage, vein inflammation, immune-system reactions and hemolysis. No serious injuries, deaths or other adverse events had been reported when the recall was announced.

This is primarily a hospital and clinical-care recall, rather than something most consumers would have at home.

🚩 Baxter saline — possible fiberglass particles

Also worth noting: Baxter recalled two lots of 500 mL 0.9% Sodium Chloride Injection on August 26 because the solution may contain fiberglass particulate matter. (U.S. Food and Drug Administration)

Affected lots are Y495523 and Y495523A, expiration October 31, 2027. They were distributed to health-care providers and distributors in 14 states, including Florida, Illinois, New Jersey, New York, Texas and Virginia.

FDA says infused fiberglass particles could cause blood-vessel blockage, pulmonary embolism, permanent organ damage or death, as well as inflammation and allergic reactions. Baxter had received no related adverse-event reports as of August 25.

Other agency checks

CPSC: We found no new August 28 consumer-product recall. The agency’s newest major actions remain yesterday’s August 27 batch, led by the expanded 3.6 million Cuisinart grill-brush recall and the magnetic-building-block warning involving a child who required surgery. (U.S. Consumer Product Safety Commission)

NHTSA: We found no new urgent national vehicle-recall alert dated August 28.

USDA FSIS: We found no new meat, poultry or processed-egg recall or public-health alert dated August 28. The latest recall surfaced in current official results remains the August 17 Indus Foods pickled goat and chicken recall. (FSIS)

FDA: The B. Braun saline action is the newest posting on FDA’s recall list today. (U.S. Food and Drug Administration)

For a general consumer-news roundup, today is fairly quiet. The B. Braun action is medically serious but primarily institutional, so I would probably treat it as a brief unless you’re doing a broader piece on the recent cluster of contaminated IV-fluid recalls.